A federal court judge expects to rule by late October on whether the Food and Drug Administration can require new, strident text warnings and images to be added to cigarette packaging that could affect the one in five African Americans who still smoke.
At a Sept. 21 hearing in the U.S. District Court for the District of Columbia that ran well over its allotted time, tobacco-industry lawyers told Judge Richard J. Leon that the FDA, part of the U.S. Department of Health and Human Services, is free to tell Americans how to live, counseling them not to eat fatty foods, drink or smoke. But the public health agency cannot "conscript" cigarette makers into an antismoking brigade to act as the government's "mouthpieces," said Floyd Abrams, an attorney who specializes in First Amendment cases and who represents one of five cigarette makers seeking the preliminary injunction.
"This is not an ordinary product," countered Mark B. Stern, an attorney for the U.S. Department of Justice. "This kills 440,000 people a year."
Asked by the judge whether the government could similarly warn chocolate lovers by adding photos of dentists with drills on candy labels, Stern said that the federal government's interest "isn't in preventing cavities. It's preventing death."
Earlier this summer, the FDA quickly flexed regulatory authority granted by Congress and released graphic warning labels for cigarettes that represented the most significant change to U.S. cigarette packages in 25 years.
Among the images: a man smoking through the tracheotomy hole in his throat, with the warning that "cigarettes are addictive"; a sobbing woman next to a warning about secondhand smoke's link to fatal lung disease for nonsmokers; and a pudgy baby menaced by a puff of smoke with the warning that tobacco smoke "can harm your children."
The five cigarette manufacturers struck back just as quickly, filing a request for a preliminary injunction that was heard at the Sept. 21 hearing. Should Leon grant the injunction in the high-profile case, the introduction of images labeled "dire" by some and "bold" by others could be postponed.
While smoking rates declined modestly among all Americans from 2005 to 2010, resulting in 3 million fewer smokers, 20.6 percent of African Americans still smoke, according to the Centers for Disease Control and Prevention. African Americans make up the third-highest percentage of smokers by ethnicity, lower than the 31.4 percent of Native Americans and the 21 percent of whites who smoke, the CDC reports. While African Americans smoke fewer cigarettes than whites, they suffer disproportionately from deadly and preventable diseases associated with smoking, according to the American Lung Association.
In its 55-page written statement to the district court, the FDA argued that current cigarette warnings, in place since 1984, are virtually "invisible" and require a college reading level to fully grasp. Citing research conducted around the globe, the agency says that adding photographs and graphics helps make the public health message easier to digest and more memorable for younger, less educated consumers, and could help reverse years of misinformation.
"For decades, cigarette manufacturers systematically deceived the public and regulators regarding the health risks and addictiveness of their products," the FDA response notes. "Congress, fully aware of that history, enacted the new warning requirement to inform consumers of the health risks of cigarettes that the manufacturers had so long been at pains to obscure."
If the FDA prevails, the United States would become the 40th country in the world to adopt such prominent cigarette warnings, according to Thomas J. Glynn, director of cancer science and trends for the American Cancer Society. The group was among nine health organizations to join an amicus brief in support of the FDA filed by Public Citizen.
"If we don't get the graphic warnings, we will lose an opportunity to increase the trajectory that we're on right now of bringing tobacco use down," Glynn said.
At stake, argued plaintiffs that include R.J. Reynolds Tobacco, is their First Amendment right to free commercial speech. Like the FDA, the plaintiffs have attracted a host of friend-of-the-court briefs, including one filed by the Washington Legal Foundation, a legal powerhouse that has successfully protected commercial free speech rights before the Supreme Court.
According to Richard A. Samp, chief counsel for the Washington Legal Foundation, the government is entitled to ask companies engaged in commerce to provide full disclosure of information when consumers need it to make a rational choice. But the "skull and crossbones" warnings required by the FDA would "confiscate" much of the space on cigarette packages for dubious reasons, Samp said.
"It seemed to us that the government appears to be violating First Amendment rights for no reason other than a punitive motive," he said. "In this case, I don't think anyone seriously argues that people who buy cigarettes don't know the risks they are taking on."
Still, public health advocates have attempted to weave in such images as part of comprehensive smoking-cessation approaches that include dampening interest through higher cigarette prices, smoke-free policies and forceful public education campaigns.
Last month the city of New York credited such a sweeping approach with reducing the city's adult smoking rate to 14 percent, an all-time low. The city's department of health also wanted to require retailers to post signs depicting the graphic effects of tobacco use, but the law was overturned and is pending appeal.
Within the next few years, Samp anticipates that either the New York City case, another case filed by cigarette manufacturers in Kentucky or the R.J. Reynolds lawsuit could ultimately land at the Supreme Court.
Diedtra Henderson is a freelance science and technology writer.